ASP Cares – FDA 483, Mar 2, 2017

An FDA inspection of American Specialty Pharmacy, an outsourcing facility located in San Antonio, TX, was conducted from February 21 to March 2, 2017. The inspection, led by Investigator Jason R. Caballero, resulted in the issuance of a Form FDA 483 to Jacqueline E. Esqueda, Pharmacist In Charge, on March 2, 2017.

Two observations were noted:

1. **Facility Construction and Operations:** The building used for drug product manufacturing, processing, packing, or holding lacked suitable construction to facilitate cleaning, maintenance, and proper operations. Specifically, a sink was observed approximately four feet from the laminar airflow hood in the Sterile Prep Room on February 21, 2017. This laminar airflow hood is used for aseptic processing of sterile drug products.

2. **Deficient Container Labels:** The container labels for the outsourcing facility's drug products were found to be deficient, lacking information required by section 503B(a)(10)(A) and (B). * The drug product label for Glycerin 100%, 4 mL, Lot #01262017@1, NDC #00000-0505-4, did not include the statement "Office Use Only." * The container label for Glycerin 100%, Sterile, 16 mL, Lot